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[研究方案八。人体研究的伦理规范]

[Research protocol VIII. The ethics of research on human subjects].

作者信息

Miranda-Novales María Guadalupe, Villasís-Keever Miguel Ángel

机构信息

Instituto Mexicano del Seguro Social, Coordinación de Investigación en Salud, Unidad de Investigación en Análisis y Síntesis de la evidencia, Ciudad de México, México.

出版信息

Rev Alerg Mex. 2019 Jan-Mar;66(1):115-122. doi: 10.29262/ram.v66i1.594.

Abstract

Research on human subjects cannot occur if it does not comply with these ethical principles: autonomy, beneficence and justice. The historical antecedents that emphasized the need to have documents to guide the researchers' behavior point to regrettable events for humanity. Even though the first recommendations were published more than 50 years ago in the Declaration of Helsinki, it is possible to find examples of investigations that have been conducted without complying with the aforementioned ethical principles. Approval by an ethics committee is required by law for all the research projects that involve human subjects. At present, virtually all scientific journals require the proof of approval and they assess whether the risks which participants were subjected to in the studies were necessary, and they also assess whether the benefits that were obtained from the research justify its conduction. Meeting the criteria that are required in order to conduct a study in an ethical manner should not be seen as an imposition; but as a moral commitment that has been established between the researcher and the participants of the study.

摘要

如果不遵守这些伦理原则

自主、行善和公正,就无法开展人体研究。强调需要有文件来指导研究人员行为的历史先例指向了人类的一些令人遗憾的事件。尽管50多年前就在《赫尔辛基宣言》中发布了首批建议,但仍能找到一些未遵守上述伦理原则而进行的调查实例。法律要求所有涉及人体受试者的研究项目都必须获得伦理委员会的批准。目前,几乎所有科学期刊都要求提供批准证明,它们会评估研究中受试者所面临的风险是否必要,还会评估从研究中获得的益处是否足以证明研究的合理性。以符合伦理的方式开展研究所需满足的标准不应被视为一种强制要求;而应被视为研究人员与研究参与者之间确立的一种道德承诺。

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